Unipentintin Capsule 100 mg (Gabapentin)

Adult dose

1. Epilepsy 1) Monotherapy and adjunctive therapy in patients aged 13 years and older To achieve a maintenance dose of 900 mg/day of gabapentin, titrate gradually over the first 3 days of treatment as follows: Day 1: Administer one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug may be administered three times daily (gabapentin 900 mg/day). The dose may be increased to 1,200 mg/day of gabapentin, and the total daily dose must not exceed 2,400 mg of gabapentin. (There are insufficient data on the safety and efficacy of doses exceeding 2,400 mg/day of gabapentin.) 3) The duration of treatment should depend on clinical need. Long-term treatment is generally required for epilepsy. Although there is no evidence of a rebound phenomenon (an increase in the frequency of epileptic seizures due to sudden discontinuation of treatment), sudden discontinuation of antiepileptic drugs in patients with epilepsy may cause status epilepticus. If this drug must be discontinued or administered concomitantly with another antiepileptic drug, the change should be made gradually over at least 1 week. 2. Neuropathic pain (Neuropathic pain) 1) Adults (18 years and older): To achieve a maintenance dose of 900 mg/day of gabapentin, titrate gradually over the first 3 days of treatment as follows: Day 1: Administer one 300 mg capsule of this drug once daily, or one 100 mg capsule of this drug three times daily (gabapentin 300 mg/day) Day 2: Administer one 300 mg capsule of this drug twice daily, or two 100 mg capsules of this drug three times daily (gabapentin 600 mg/day) From Day 3: Administer one 300 mg capsule of this drug three times daily, or three 100 mg capsules of this drug three times daily (gabapentin 900 mg/day) Alternatively, as an initial dose, one 300 mg capsule of this drug may be administered three times daily (gabapentin 900 mg/day). If necessary, the dose may be increased to 1,800 mg/day of gabapentin within one week, and the total daily dose must not exceed 3,600 mg of gabapentin. The total daily dose of this drug should be divided into 3 doses. 2) The safety and efficacy of treatment for neuropathic pain for more than 5 months have not been evaluated. 3. Debilitated patients In debilitated patients with low body weight or patients who have undergone transplantation, increase the dose of this drug in increments of 100 mg. 4. Elderly patients Dosage adjustment may be necessary due to age-related decline in renal function (see table). 5. Patients with renal impairment (creatinine clearance of 80 mL/min or less) or patients receiving hemodialysis: Dosage adjustment is required based on the following table. 1) Dosage for patients with renal impairment: Renal function: creatinine clearance (mL/min) Total daily dosea (mg/day) ≥80 900∼2,400 50∼79 600∼1,800 30∼49 300∼900 15∼29 150b∼600 <15 150b∼300 a: The total daily dose should be divided into 3 doses. b: Administer 3 × 100 mg every 2 days. In patients with creatinine clearance below 15 mL/min, the dose should be reduced in proportion to creatinine clearance. 2) Dosage for patients receiving hemodialysis Initial dose: 300~400 mg of gabapentin is recommended. Maintenance dose: Administer 200~300 mg of gabapentin after 4 hours of hemodialysis; do not administer this drug on days when hemodialysis is not performed. 6. Method and duration of administration 1) Swallow this drug whole with plenty of fluid. It may be taken with or without food. When administering 3 times daily, take care that the interval between doses does not exceed 12 hours to prevent recurrence of seizures. 2) If a dose of this drug is missed (if 12 hours or more have elapsed since the last dose), the physician should determine whether an additional dose should be taken to make up for the missed dose. 3) When administered concomitantly with antacids containing magnesium or aluminum, this drug should be administered at least 2 hours after the antacid. This can substantially reduce the decrease in the bioavailability of this drug. 4) The duration of treatment with this drug should depend on clinical need. If the dose of this drug is reduced, treatment is discontinued, or this drug is replaced with another alternative drug, the change should be made gradually over at least 1 week (a longer period may be necessary at the prescriber's discretion). 5) To reduce the main adverse reactions, such as somnolence, dizziness, fatigue, and ataxia, the first dose on the first day should be taken at bedtime.

Child dose

2) Adjunctive therapy in children aged 3 years to 12 years Day 1: Administer gabapentin 10 mg/weight(kg) Day 2: Administer gabapentin 20 mg/weight(kg) From day 3: Administer gabapentin 30 mg/weight(kg) The dose may be increased, if necessary, to a maximum of 40 mg per kg of body weight daily. When administering this medicine, the total daily dose should be divided into 3 doses.

This drug may increase the risk of suicidal thoughts and behavior, so if there are changes in mood or behavior during treatment, it is essential to consult a doctor immediately. Discontinuing the medication abruptly may lead to more frequent seizures or progression into continuous epilepsy status; therefore, the dosage should be gradually reduced in accordance with the doctor's instructions. Serious side effects such as pancreatitis may occur; if there are symptoms like abdominal pain, nausea, or recurrent vomiting, the medication should be stopped immediately and a hospital visit is necessary. Particularly in children, adverse psychiatric reactions such as emotional instability, aggression, decreased concentration, and hyperactivity may occur, thus caregivers should observe them closely. This drug may cause drowsiness or dizziness, so caution is needed when driving or operating dangerous machinery. Taking this drug along with central nervous system depressants or narcotics may lead to respiratory depression or severe sedation; therefore, co-administration should be discussed with a doctor. Patients with poor kidney function may need dosage adjustment, and women who are pregnant or planning to become pregnant must consult a physician before taking the drug. This medication can cause life-threatening side effects such as allergic reactions, severe skin rashes, anaphylaxis, and angioedema; immediate discontinuation and hospital visit are required if there are symptoms like skin rash or difficulty breathing. Sudden cessation after long-term use may lead to withdrawal symptoms such as anxiety, insomnia, tremors, and headaches; thus, the dosage should be adjusted according to the doctor’s instructions. The drug should be used more cautiously in specific patient groups including children, elderly patients, and those with a history of psychiatric illness, and any unusual symptoms during treatment must be reported to healthcare professionals immediately. While taking the drug, regular checks of weight and vision changes should be conducted, and any unusual symptoms should be discussed with a doctor promptly. This drug must be stored in its original container and kept out of reach of children.

Suicidal impulses, suicidal behavior, depression, abnormal changes in mood and behavior, hemorrhagic pancreatitis, emotional instability, hostility, thought disorder, hyperactivity, weakness, apathy, facial edema, hypertension, constipation, abnormal teeth, diarrhea, dyspepsia, increased appetite, thirst, nausea, vomiting, leukopenia, peripheral edema, weight gain, fractures, myalgia, amnesia, ataxia, confusion, impaired coordination, dizziness, dysphonia, insomnia, neuroexcitable reaction, nystagmus, drowsiness, thought disorder, tremor, single contraction, cough, pharyngitis, rhinitis, abrasion, acne, itching, rash, amblyopia, diplopia, erectile dysfunction, weakness, lethargy, facial edema, allergy, generalized edema, weight loss, chills, feelings of unfamiliarity, lethargy, alcohol intolerance, hangover effect, hypotension, angina, peripheral vascular disorder, palpitations, tachycardia, migraine, noise, atrial fibrillation, heart failure, thrombophlebitis, myocardial infarction, cerebrovascular accident, pulmonary thromboembolism, ectopic beats, bradycardia, immature atrial contraction, pericardial friction, heart block, pulmonary embolism, hyperlipidemia, hypercholesterolemia, pericardial effusion, pericarditis, loss of appetite, bloating, gingivitis, glossitis, gum bleeding, thirst, stomatitis, increased salivation, gastroenteritis, hemorrhoids, bloody stools, fecal incontinence, hepatomegaly, dysphagia, belching, pancreatitis, gastric ulcer, colitis, oral vesicles, tooth discoloration, angular cheilitis, salivary gland hypertrophy, lip bleeding, esophagitis, hiatal hernia, hematemesis, proctitis, irritable bowel syndrome, rectal bleeding, esophageal spasm, hyperthyroidism, hypothyroidism, thyroid enlargement, low estrogen, ovarian failure, epididymitis, testicular swelling, Cushing's syndrome, contusions like bruising due to trauma, anemia, lymphadenopathy, thrombocytopenia, leukocytosis, lymphocytosis, non-Hodgkin's lymphoma, prolonged bleeding time, arthralgia, tendonitis, arthritis, joint stiffness, joint swelling, positive Romberg test, costochondritis, osteoporosis, pouchitis, contracture, dizziness, hyperactivity, sensory abnormality, decreased or absent reflexes, increased reflexes, anxiety, hostility, CNS tumors, syncope, dream disorder, aphasia, sensory impairment, intracranial hemorrhage, hypotonia, paresthesia, incomplete paralysis, hypertonia, hemiplegia, facial paralysis, confusion, cerebellar dysfunction, positive Babinski sign, decreased proprioception, subdural hematoma, apathy, hallucinations, decreased or absent libido, restlessness, paranoia, depersonalization, dysphoria, hyperesthesia, states of hallucination, suicidal impulses, psychosis, chorea, athetosis, oral motor disorders, brain disease, nerve paralysis, personality disorders, increased libido, organic suppression, apraxia, fine motor control disorders, meningitis, local focal seizures, hypersensitivity, decreased motor function, mania, neurosis, hysteria, antisocial reactions, suicidal behavior, pneumonia, nosebleeds, dyspnea, apnea, mucositis, aspiration pneumonia, hyperventilation, hiccups, laryngitis, nasal congestion, nasal dripping, bronchospasm, hypoventilation, pulmonary edema, hair loss, eczema, dry skin, increased sweating, hives, hirsutism, seborrhea, cysts, herpes simplex, shingles, skin discoloration, skin papules, photosensitivity, leg ulcers, seborrheic dermatitis, psoriasis, epidermal peeling, maceration, skin nodules, necrosis, localized swelling, hematuria, urinary disorders, incontinence, cystitis, urinary retention, urinary incontinence, vaginal bleeding, amenorrhea, menstrual irregularities, menorrhagia, breast cancer, anovulation, ejaculation disorders, renal pain, leukorrhea, genital itching, kidney stones, acute renal failure, anuria, diabetes, nephritis, nocturnal enuresis, pyuria, urinary urgency, vulvodynia, mastalgia, testicular pain, vision abnormalities, cataracts, conjunctivitis, dry eyes, eye pain, glare, bilateral or unilateral ptosis, eye bleeding, chalazion, hearing loss, ear pain, tinnitus, inner ear inflammation, ear inflammation, taste loss, taste abnormalities, eyelid twitching, eye fullness, eye itching, accommodation disorders, tympanic membrane perforation, sensitivity to noise, ocular fixation abnormalities, watery eyes, retinal disease, glaucoma, iritis, corneal disorders, impaired lacrimal function, eye degeneration, blindness, retinal degeneration, miosis, choroid-retinal inflammation, strabismus, Eustachian tube dysfunction, inner ear inflammation, outer ear inflammation, olfactory abnormalities, drowsiness, hyperactivity, hostility, emotional instability, dizziness, bronchitis, respiratory infections, dehydration, infectious mononucleosis, hepatitis, blood coagulation disorders, loss of warning symptoms, laryngeal neuralgia, sleepwalking, pseudo croup, hoarseness, tongue paralysis, coma, loss of consciousness, hypersomnia, unclear speech, withdrawal symptoms (anxiety, insomnia, nausea, pain, sweating, tremors, headache, abnormal sensations, lethargy), anaphylaxis, angioedema, hypotension, toxic epidermal necrolysis, erythema multiforme, falls, gynecomastia, hallucinations, hepatitis, hypersensitivity including systemic reactions, hyponatremia, jaundice, loss of consciousness, chorea athetosis, movement disorders, hypertonia, myotonic cramps, palpitations, pancreatitis, sexual dysfunction (changes in libido, ejaculation disorders, hyperesthesia)

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the drug's effectiveness and safety for a long time.

Appearance

A hard capsule with white or light gray powder inside.

Package unit

30 capsules/bottle, 300 capsules/bottle